BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 1800889 · Received August 9, 2010

    Report

    Report Number
    MW5017050
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE: SURGEON PERFORMING TROCHANTERIC ROUTING TO CLEAR OUT THE LATERAL ASPECT OF THE SUPERIOR FEMUR NECK WHEN THE ROUTER BROKE -S-ROM PILOT II- APPROX 3 INCHES STAINLESS STEEL- WITHIN THE MEDULLARY CANAL OF THE FEMUR. ATTEMPTS TO RETRIEVE THE STEM OF ROUTER FROM THE CANAL WERE UNSUCCESSFUL- OTHER OPTIONS FOR REMOVAL WOULD HAVE SIGNIFICANTLY WEAKENED THE PT'S FEMUR. SURGEON DETERMINED IT WAS IN THE BEST INTEREST OF THE PT TO LEAVE THE STEM IN THE MEDULLARY CANAL BECAUSE IT WOULD NOT IMPEDE PLACEMENT OF THE PROSTHETIC STEM AND IT WAS A STERILE DEVICE. SURGERY THEN PROCEEDED AS PLANNED. DIAGNOSIS OR REASON FOR USE: ROUTING DEVICE - CONE REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY S-ROM PILOT II JDI DEPUY ORTHOPAEDICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other